Task shifting in the care for patients with hand osteoarthritis. Protocol for a randomized controlled non-inferiority trial.

BACKGROUND: Current health policy states that patients with osteoarthritis (OA) should mainly be managed in primary health care. Still, research shows that patients with hand OA have poor access to recommended treatment in primary care, and in Norway, they are increasingly referred to rheumatologist consultations in specialist care. In this randomized controlled non-inferiority trial, we will test if a new model, where patients referred to consultation in specialist health care receive their first consultation by an occupational therapy (OT) specialist, is as safe and effective as the traditional model, where they receive their first consultation by a rheumatologist. More specifically, we will answer the following questions: 1. What are the characteristics of patients with hand OA referred to specialist health care with regards to joint affection, disease activity, symptoms and function? 2. Is OT-led hand OA care as effective and safe as rheumatologist-led care with respect to treatment response, disease activity, symptoms, function and patient satisfaction? 3. Is OT-led hand OA care equal to, or more cost effective than rheumatologist-led care? 4. Which factors, regardless of hand OA care, predict improvement 6 and 12 months after baseline? METHODS: Participants will be patients with hand OA diagnosed by a general practitioner and referred for consultation at one of two Norwegian departments of rheumatology. Those who agree will attend a clinical assessment and report their symptoms and function in validated outcome measures, before they are randomly selected to receive their first consultation by an OT specialist (n = 200) or by a rheumatologist (n = 200). OTs may refer patients to a rheumatologist consultation and vice versa. The primary outcome will be the number of patients classified as OMERACT/OARSI-responders after six months. Secondary outcomes are pain, function and satisfaction with care over the twelve-month trial period. The analysis of the primary outcome will be done by logistic regression. A two-sided 95% confidence interval for the difference in response probability will be formed, and non-inferiority of OT-led care will be claimed if the upper endpoint of this interval does not exceed 15%. DISCUSSION: The findings will improve access to evidence-based management of people with hand OA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03102788. Registered April 6th, 2017, https://clinicaltrials.gov/ct2/show/NCT03102788?term=Kjeken&draw=2&rank=1 Date and version identifier: December 17th, 2020. First version.

Effect of home-based hand exercises in women with hand osteoarthritis: a randomised controlled trial.

BACKGROUND: Hand exercises are recommended for patients with hand osteoarthritis (HOA), though evidence for their effect is conflicting. OBJECTIVE: To evaluate, in a randomised controlled trial, the effect of HOA information plus home-based hand exercises (exercise group) compared with information only (control group) in women with HOA. METHODS: Interventions were delivered by two occupational therapists. Exercise group participants received eight follow-up calls over the 3-month study and recorded adherence, pain after exercises and adverse events in a diary. Primary outcome was activity performance measured after 3 months by the Patient-Specific Functional Scale (PSFS), with a range of 0-10. Secondary outcomes were measurements of hand function, disease activity, symptoms and number of responders to treatment according to the OMERACT-OARSI criteria. RESULTS: Of 80 women randomised (40 : 40) (mean age (SD) 60.8 years (7.0)), follow-up was 89% (n=71). An intention-to-treat analysis was performed. The adjusted mean difference for the exercise versus control group was 1.4 points (95% CI 0.6 to 2.2, effect size 1.0) for the PSFS score. Thirteen patients in the exercise group versus three participants in the control group reached a positive minimal clinical important difference of 2.2 points in the PSFS total score, while none versus two, respectively, had a negative change (p=0.007). For secondary outcomes, significant mean differences were found in grip strength and thumb web space, in fatigue, joint pain and the Functional Index for HOA activity performance scores. Sixteen exercise-group participants fulfilled the OMERACT-OARSI response criteria versus two control-group participants (p<0.001). CONCLUSIONS: Hand exercises were well tolerated and significantly improved activity performance, grip strength, pain and fatigue in women with HOA. TRIAL REGISTRATION NUMBER: ISRTCN79019063.